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Treatment Interruption for HIV (SCOPE-ATI Trial)

N/A
Recruiting
Led By Steven Deeks, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18
Antiretroviral therapy for at least 12 months
Must not have
Severe hepatic impairment (Child-Pugh Class C) or unstable liver disease
Recent or prior (within past 5 years) malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 through month 12
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how HIV and the host interact at the earliest stages, by having volunteers with HIV stop antiretroviral therapy (ART) and then have intensive studies done 2-3 times/week. Most will resume therapy within 3 weeks.

Who is the study for?
This trial is for adults over 18 with HIV who've been on antiretroviral therapy (ART) for at least a year, have undetectable virus levels, and a CD4+ count above 350. They must use two contraception methods if they can have children and agree to counseling to prevent HIV spread. It's not for those with severe kidney or liver disease, active hepatitis B or C, recent cancer, heart issues, or using certain other drugs.
What is being tested?
The study examines what happens when people with HIV stop taking their ART medications temporarily. Participants will halt their treatment under close monitoring with frequent check-ups to see how the virus behaves and how the body responds without medication.
What are the potential side effects?
Since this trial involves stopping ART medication rather than adding new treatments, side effects may include an increase in viral load and potential weakening of the immune system during the interruption period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been on antiretroviral therapy for at least a year.
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I can have children and agree to use two forms of birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe liver problems or unstable liver disease.
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I have had cancer in the last 5 years.
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I am currently taking drugs that affect my immune system.
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My kidney function is severely reduced.
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I am on a specific HIV medication and cannot change it.
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I have serious heart or brain blood vessel problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 through month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 through month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute retroviral syndrome
CD4+ T cell decline
Failure to re-suppress
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment Interruption ArmExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,910 Total Patients Enrolled
Chan Zuckerberg BiohubOTHER
1 Previous Clinical Trials
600 Total Patients Enrolled
Steven Deeks, MDPrincipal InvestigatorUniversity of California, San Francisco
7 Previous Clinical Trials
1,084 Total Patients Enrolled

Media Library

Treatment Interruption Arm (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04359186 — N/A
HIV/AIDS Research Study Groups: Treatment Interruption Arm
HIV/AIDS Clinical Trial 2023: Treatment Interruption Arm Highlights & Side Effects. Trial Name: NCT04359186 — N/A
Treatment Interruption Arm (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04359186 — N/A
~4 spots leftby Jun 2025
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